Primary Device ID | 08800070233306 |
NIH Device Record Key | c13ec53c-492c-49b8-b722-57cda020cc57 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | ZENEX Guide Mini Kit |
Version Model Number | ZENGMATKIT |
Company DUNS | 694625347 |
Company Name | Izenimplant Co., Ltd. |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | true |
MRI Safety Status | MR Conditional |
Human Cell/Tissue Product | false |
Device Kit | false |
Device Combination Product | false |
Single Use | false |
Lot Batch | true |
Serial Number | false |
Manufacturing Date | true |
Expiration Date | false |
Donation Id Number | true |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | true |
OTC Over-The-Counter | false |
Device Issuing Agency | Device ID |
---|---|
GS1 | 08800070233306 [Primary] |
NDP | Accessories, Implant, Dental, Endosseous |
Steralize Prior To Use | true |
Device Is Sterile | false |
[08800070233306]
Moist Heat or Steam Sterilization
[08800070233306]
Moist Heat or Steam Sterilization
[08800070233306]
Moist Heat or Steam Sterilization
[08800070233306]
Moist Heat or Steam Sterilization
[08800070233306]
Moist Heat or Steam Sterilization
[08800070233306]
Moist Heat or Steam Sterilization
[08800070233306]
Moist Heat or Steam Sterilization
[08800070233306]
Moist Heat or Steam Sterilization
[08800070233306]
Moist Heat or Steam Sterilization
[08800070233306]
Moist Heat or Steam Sterilization
[08800070233306]
Moist Heat or Steam Sterilization
[08800070233306]
Moist Heat or Steam Sterilization
[08800070233306]
Moist Heat or Steam Sterilization
[08800070233306]
Moist Heat or Steam Sterilization
[08800070233306]
Moist Heat or Steam Sterilization
[08800070233306]
Moist Heat or Steam Sterilization
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2023-10-02 |
Device Publish Date | 2023-09-22 |
08800070231777 | R-System |
08800070231760 | T-System |
08800070231753 | I-System |
08800070231708 | ZENGMKIT |
08800070233306 | T-System All-in-One |